Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department

This study is currently recruiting participants.

Verified August 2012 by Children's Hospitals and Clinics of Minnesota

Sponsor:

Information provided by (Responsible Party):

Children's Hospitals and Clinics of Minnesota

ClinicalTrials.gov Identifier:

NCT01514084

First received: January 12, 2012

Last updated: August 8, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2012
Last Updated Date	August 8, 2012
Start Date ^ICMJE	February 2012
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Cosmetic outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ] Cosmetic Visual Analog Score and the Wound Evaluation Score
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01514084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 17, 2012)	Satisfaction score [ Time Frame: 6 months ] [ Designated as safety issue: No ] Visual analog scale; left end labeled "Dissatisified" and right end labeled "Very satisfied"
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Cosmetic Outcomes and Patient Satisfaction After Facial Laceration Repair in the Emergency Department
Official Title ^ICMJE	Not Provided
Brief Summary	Facial lacerations are commonly treated in the emergency department. The nature of the injury leads to a great deal of concern about the long-term cosmetic appearance of the wounds. Research Questions What is the association between wound characteristics, wound management in the ED, patient satisfaction in the ED, and patient-rated cosmetic appearance of sutured wounds? Is there a difference noted among ED providers with different levels of training? Is there an association between initial satisfaction scores and wound outcome? Is there an association between short term and long term wound scores? Design This is a non-randomized, prospective, observational study of patients who present to the ED seeking treatment for facial laceration repair.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Pediatric emergency department
Condition ^ICMJE	Facial Lacerations
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	PEM group Patients whose lacerations have been repaired by PEM trained physicians. GP group Patients whose lacerations have been repaired by general pediatricians. PNP group Patients whose lacerations have been repaired by PNPs. RN group Patients whose lacerations have been repaired by suture RNs.
Publications *	Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	160
Estimated Completion Date	January 2014
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Families presenting to the ED for repair of facial laceration will be approached for study inclusion if: Their child seeking treatment is less than 18 years of age The laceration was sustained less than 12 hours prior to presentation to Children's ED They speak English Exclusion Criteria: Families presenting to the ED for repair of facial laceration will be excluded from study participation if they: Are medically complex children Have a history of pre-existing coagulopathy or collagen vascular disease Have a history of immunodeficiency or diabetes mellitus Are suspected of non-accidental trauma Have wounds that could be approximated by tissue adhesives Have animal or human bites Have gross contamination Have puncture wounds Have lacerations of tendon/nerve/cartilage Have scalp lacerations Do not speak English
Gender	Both
Ages	up to 17 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01514084
Other Study ID Numbers ^ICMJE	1108-081
Has Data Monitoring Committee	Not Provided
Responsible Party	Children's Hospitals and Clinics of Minnesota
Study Sponsor ^ICMJE	Children's Hospitals and Clinics of Minnesota
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Children's Hospitals and Clinics of Minnesota
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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